# K120381: Q50 Plus Stent Graft Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Qxmedical, LLC
- Decided: Feb 24, 2012 after 17 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003495 (2001). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091624: Stent Graft Balloon Catheter, Via Biomedical, Inc. (2009) Summary page 1.

## Most influential descendants
- K192786: Gatekeeper Balloon Catheter (2020), 0 descendants of its own
- K172567: GORE Molding and Occlusion Balloon Catheter (2018), 0 descendants of its own

## Indications for use
The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

Source page: https://510kreport.com/device/K120381
Methodology: https://510kreport.com/methodology